Label: BORTONS MENTICOL- ethyl alcohol, menthol liquid

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 14, 2010

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Drug Facts/Medicamento

    Active Ingredients/Ingredients activo            Purpose/Proposito

    Ethyl Alcohol/Alcohol Etilico 69.5%             Antiseptic/Antiseptico

    Methol/Mentol 1%                                      Topical Anagesic/Anagesico topico


  • PURPOSE

     USES/USO  

    First Aid to help reduce the risk of infection in minor cuts and scrapes/Primeros Auxillos para ayudar a reducir el riegsgo de infeccion en cortadas menores y raspones


    For temporary relief of itching associated with insect bites. Para ailvio temporal de: comezon asociado con picaduras de insecto

  • WARNINGS

    Warnings/Advertencias

    For external use only. do not use in or near the eyes. In case of deep or puncture wounds consult your doctor/ Para uso externo solamente. No para uso serca de los ojos. En caso de erina profunda, consulte con un doctor



    Flammable, keep away from fire or flame. Flamable, mantenga alejado del fuego or flama



    Avoid contact with the eyes/Eveitar contacto con los oj



    If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor./Si la condicion empeora o si los sintomas persisten por mas de 7 dias o desaparecen u ocurren nuevamente en pocos dias, descontinue el uso de este producto y consulte a un doctor



    Keep out of reach of children/Mantengase alejado del alcance de los ninos



    If swallowed, get medical help or contact Poison Control Center right away. Si es ingerido, obtenga ayuda medica o contacte el centro de control de envenamientos de inmediato.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS/DIRECCIONES

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Adultos y ninos de 2 anos de edad en adelante: Aplica en el area afectada no mas de 3 a 4 veces diarias

    Apply to skin directly or with clean gauze, cotton, or swab./Aplicar directamente a la piel o con una gasa limpia, algodon, o isopo

    Children under 2 years of age: consult a doctor/Ninos menores de 2 anos de edad: consultar a un doctor.

  • INACTIVE INGREDIENT

    FDandC Red/Rojo 40, water/ agua

  • INFORMATION FOR PATIENTS

    For you protection, this bottle has an imprinted seal around the cap. Do not use if tamper evident seal is missing, tampered, broken or destroyed./Para su proteccion, esta botella tiene un sello impreso alrededor de la tapa. No use si el sello falta, ha sido alterado, roto o destruido

  • SPL UNCLASSIFIED SECTION

    Distributed by/Distribuido por

    J-MARK International Inc.

    0819-03925

    Panama


    Made In/Hecho en Panama

    Expiration Date/Fecha de Expiracion 12/2015


  • PRINCIPAL DISPLAY PANEL

    Borton's Menticol

    First Aid Antiseptic

    Pain Relieving Liniment

    Linimentoantiseptico para primeros

    auxilios y aliviar el dolor



    Net contents/Contenido Neto 16 fl oz (473 ml)

  • PRINCIPAL DISPLAY PANEL

    frontlabel

  • PRINCIPAL DISPLAY PANEL

    backlabel

  • INGREDIENTS AND APPEARANCE
    BORTONS MENTICOL 
    ethyl alcohol, menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50790-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69.5 mL  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50790-200-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33305/06/2010
    Labeler - J-Mark International Inc (853770001)
    Registrant - J-Mark International Inc (853770001)
    Establishment
    NameAddressID/FEIBusiness Operations
    J-Mark International Inc853770001manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!